When physician is removed, does risk increase?
California now permits non-physicians to perform abortions, a move that supporters say guarantees access, while opponents claim is bad medicine.
Over the last 4 years 30 states passed legislation aimed at restricting access to abortion, a trend that California bucked when the state passed Assembly bill 154 in 2013, enabling mid-level providers to offer medication and surgical abortions.
Mary Davenport, MD, FACOG, an obstetrician-gynecologist practicing in the San Francisco area and a medical director of the Magnificat Maternal Health Program in Nigeria, called the state’s decision “bad policy” based on “bad research.”
Davenport promotes a technique to reverse medical abortions that use RU-486 — www.abortionpillreversal.com and http://www.medpagetoday.com/OBGYN/GeneralOBGYN/50164
At the American Association of Pro Life Obstetricians and Gynecologists here last month, Davenport critiqued a study by Tracy Weitz, PhD [http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3673521/ see Abstract and excerpts below], published in the American Journal of Public Health, which compared safety outcomes among physicians and non physicians performing surgical abortions, also known as aspiration or “vacuum” abortions.
Davenport argued that Weitz had a predetermined conclusion before even beginning her research.
“She’s a brilliant woman. She had a firm ideology about abortion access, and then she did a study that was instrumental in getting this law passed in the legislature,” Davenport said.
Weitz’s prospective observational study was designed to measure the safety among women whose abortions were administered by either nonphysicians — nurse practitioners, physicians assistants or nurse midwives — or physicians.
The researchers chose a noninferiority design because “we anticipated a slightly higher number of complications among newly trained NPs, CNMs, and PAs than among the experienced physicians,” the report noted.
They established an acceptable risk difference of 2% before the study began. This meant non physicians would need to demonstrate complication levels that were “no worse” than 2% greater than experienced physicians. Physicians, on average had 14 years of practice performing abortions, compared with 1.5 years for mid-level providers.
The risk level researchers set was approved by the Data and Clinical Safety Monitoring Committee, which evaluates ethical and clinical issues, the report noted. Previous studies of complication rates ranged from 1.3% to 4.4%, according to the Committee.
Having “trained to competence” mid-level providers at five different centers, the researchers compared the rate of complications between physicians and non physicians performing a total of 11,487 early aspiration abortions — physicians handled 5,812 procedures and newly trained non physicians performed 5,675.
Weitz and her colleagues found on average a rate of 1.3% complications within 4 weeks of the procedure. They observed a rate of 1.8% for non physicians compared with 0.9% for physicians, with an unadjusted risk difference of 0.87, (with a 95% confidence interval between 0.45 and 1.29). Researchers deemed these results “clinically equivalent.”
At the AAPLOG conference, Davenport said Weitz’s complication rates were “unrealistically low.”
Davenport cited a study based on Finland’s national health registry data that showed rates of adverse events with medical abortion that were four times greater than surgical abortions — 20% and 5% respectively. That study was published in Obstetrics and Gynecology in 2009.
“If they’re not seeing [a complication]. They’re just not finding it. They don’t want to find it,” Davenport said.
In addition to concern over the complications rates, Davenport felt patients were not adequately warned about the dangers of participating.
“It says in the informed consent, being in the study does not involve added risks, but how could they put that in an informed consent, because [risk] is precisely what they were studying,” she said.
Additionally, Davenport saw a financial conflict of interest, among those reviewing the study, arguing that “they had an incredible interest in making the study look good, because their profits would be increased by not having to hire doctors to do the surgical abortions.”
She also questioned other aspects of the peer review process, noting that reviewers were not given access to original clinical charts, only abstracts.
Rebecca Wind, senior communication associate and division budget manager for the Guttmacher Institute [pro-abortion], said it isn’t standard practice for a peer reviewer to see anything apart from the article manuscript. “So, the characterization of the author as ‘not allowing’ reviewers to see patient information seems misguided, as that wouldn’t be part of the standard protocol of peer review in the first place.”
Elizabeth Nash, a senior state issues associate at the Guttmacher Institute, said the study’s goal was to investigate whether advanced practice clinicians would be “appropriate providers of services” by running a test case and evaluating the outcomes. “What it looks like here is that abortion opponents are just unhappy that the data came back and showed that advanced practice clinicians provide safe and effective services,” she said.
Nash added that Weitz’s research “stands on it’s own” regardless of her perspective on abortion. Nash emphasized the “very, very low” complication rates for abortion.
“Those who are really dedicated to women’s health are those in the reproductive health and rights community, and to attack a researcher is really a red herring,” she said.
A Patchwork of Access
Most physician-only laws were instituted in the 1970s before the concept of mid-level providers such as physician assistants developed.
As a result, it’s difficult to know whether these laws always apply to physician assistants, nurse practitioners, and certified nurse midwives or other mid-level clinicians, Nash explained.
Thirty-eight states have physician-only laws that pertain to medication abortion, according to a report from the Guttmacher Institute.
Seven of the 12 remaining states allow some categories of advanced level practitioners to provide abortions: California, Connecticut, Illinois, Montana, New York, Rhode Island, and Washington.
The Arizona Board of Nursing established a provision to allow nurses to provide abortions in 2008, but a year later the legislature enacted a physician-only law. Then in 2011, it added two more restrictions, banning abortion provision by nurses and by physician assistants. “Usually legislatures don’t get that knee-deep into scope of practice, except, of course, when it applies to abortion,” said Nash.
[3 March 2015, Shannon Firth, Washington DC, http://www.medpagetoday.com/OBGYN/GeneralOBGYN/50285 ]
Safety of Aspiration Abortion Performed by Nurse Practitioners, Certified Nurse Midwives, and Physician Assistants Under a California Legal Waiver
Am J Public Health. 2013 March; 103(3): 454–461.
Published online 2013 March. doi: 10.2105/AJPH.2012.301159
PMCID: PMC3673521 Authors: Tracy A. Weitz, PhD,corresponding author Diana Taylor, PhD, Sheila Desai, MPH, Ushma D. Upadhyay, PhD, Jeff Waldman, MD, Molly F. Battistelli, BA, and Eleanor A. Drey, MD
We examined the impact on patient safety if nurse practitioners (NPs), certified nurse midwives (CNMs), and physician assistants (PAs) were permitted to provide aspiration abortions in California.
In a prospective, observational study, we evaluated the outcomes of 11?487 early aspiration abortions completed by physicians (n?=?5812) and newly trained NPs, CNMs, and PAs (n?=?5675) from 4 Planned Parenthood affiliates and Kaiser Permanente of Northern California, by using a noninferiority design with a predetermined acceptable risk difference of 2%.
All complications up to 4 weeks after the abortion were included.
Of the 11,487 aspiration abortions analyzed, 1.3% (n=152) resulted in a complication: 1.8% for NP-, CNM-, and PA-performed aspirations and 0.9% for physician-performed aspirations. The unadjusted risk difference for total complications between NP–CNM–PA and physician groups was 0.87 (95% confidence interval [CI]=0.45, 1.29) and 0.83 (95% CI=0.33, 1.33) in a propensity score–matched sample.
Abortion complications were clinically equivalent between newly trained NPs, CNMs, and PAs and physicians, supporting the adoption of policies to allow these providers to perform early aspirations to expand access to abortion care.
Increased access to early abortion is a pressing public health need. By 2005, the number of abortion care facilities in the United States had decreased 38% from its peak in 1982.1
Although the number has since remained stable, the proportion of US counties with no facility remains high at 87%; more than one third of women aged 15 to 44 years live in these counties.2
Additionally, a large proportion of US facilities are hospitals that perform abortions only in cases of serious medical and fetal indications or facilities that offer medical abortions only up to 9 weeks of pregnancy.2
In California, more than half of the 58 counties lack a facility that provides 400 or more abortions (R.?K. Jones, PhD, Guttmacher Institute, written communication, November 2011).
Low-income and minority women are most likely to be served by public health departments or community health centers,8 most of which do not provide abortions.
These women are also more likely to be cared for by nurse practitioners (NPs) and physician assistants (PAs) than by obstetricians and gynecologists.9
… Increased emphasis has been placed on task sharing to better meet women’s health needs in the context of health care workforce shortages.13 In the United States, health professions are regulated through a patchwork of state regulations14,15 that determine who can perform abortions, a power reaffirmed by several US Supreme Court decisions.16–18
Currently, non physician clinicians can perform aspiration abortions legally in only 4 states—Montana, Oregon, New Hampshire, and Vermont.
Two additional states (Kansas and West Virginia) do not limit the performance of abortions to physicians, but non-physician clinicians have never tried to provide abortion care.
Of the remaining 44 states (Figure 1), some allow non-physician clinicians to perform medical (but not aspiration) abortions under decisions by attorneys general or health departments, and 1 state—California—passed statutory authority for that care.
As part of a larger effort to limit abortion access, several states have recently promulgated laws that specifically prohibit non-physician clinicians from performing abortions.19
For example, a 2009 Arizona law (HB 2564 and SB 1175) that precluded NPs from providing abortions resulted in the discontinuation of abortion care at several facilities that had previously been staffed exclusively by NPs.20 …
Continue reading at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3673521/